Benzonatate

Product NDC: 65162-537
11-digit product format: 651620537
Labeler code: 65162
Product ID: 65162-537_72b0f799-3f8f-4dcf-9c6e-57e796996a80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA040682
Marketing category: ANDA
Marketing start: 2010-06-04
Substance: BENZONATATE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040682-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-07-30
A040682-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040682-001	AA
A040682-002	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040682-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040682-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040682-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040682-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040682-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040682-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040682-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040682-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040682-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040682-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040682-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040682-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040682-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040682-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040682-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040682-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040682-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040682-002	AA	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZONATATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5P4DHS6ENR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197397	Internal RxNorm lookup
283417	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199a42ae-4d19-4e68-934d-dabd27084988	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-537-10	Benzonatate	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		17
65162-537-50	Benzonatate	500 in 1 BOTTLE	CAPSULE, LIQUID FILLED	500		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-537-10	EA - Each	65162-537	88bd0d96-9f66-4301-87e9-a583012ac2df	1	2012-07-24
65162-537-50	EA - Each	65162-537	2f05bf68-b994-4333-8a89-6e0abd8ba15d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS OF NY LLC]	9
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS OF NY LLC]	9
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]	2
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [NORTHWIND PHARMACEUTICALS]	2
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	2
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [MEDVANTX, INC.]	1
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE, LIQUID FILLED [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-537	BENZONATATE CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]	17	Current NDC, Legacy NDC, 2 package rows	20241025_199a42ae-4d19-4e68-934d-dabd27084988.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0151d970-fd80-482d-ad92-03015eef2618	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Redpharm Drug	4972e1e4-7eac-a770-e063-6294a90abe28	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Redpharm Drug	46e97547-23d9-114a-e063-6394a90a920b	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Amneal Pharmaceuticals LLC	199a42ae-4d19-4e68-934d-dabd27084988	2024-10-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682 ndc (product): 65162-537
Benzonatate	BENZONATATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f32014c7-bc0c-4edb-b591-7baa6664d74b	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Chartwell RX, LLC	8a17033c-1ad3-4c7a-92ee-f55756833986	2023-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
BENZONATATE	BENZONATATE	Bryant Ranch Prepack	418c4c4e-6195-4d0d-a559-ee3f10147b5b	2023-03-24	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Proficient Rx LP	19f1e761-69e9-4330-ad3c-1f1180d70cb0	2021-01-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P4DHS6ENR	BENZONATATE	104-31-4	BENZONATATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197397	benzonatate 100 MG Oral Capsule	PSN	199a42ae-4d19-4e68-934d-dabd27084988	17
283417	benzonatate 200 MG Oral Capsule	PSN	199a42ae-4d19-4e68-934d-dabd27084988	17
197397	benzonatate 100 MG Oral Capsule	SCD	199a42ae-4d19-4e68-934d-dabd27084988	17
283417	benzonatate 200 MG Oral Capsule	SCD	199a42ae-4d19-4e68-934d-dabd27084988	17
283417	benzonatate 200 MG Oral Capsule	PSN	c531b7e1-b248-4b05-9ba8-0fe7a70848a3	2
283417	benzonatate 200 MG Oral Capsule	SCD	c531b7e1-b248-4b05-9ba8-0fe7a70848a3	2
283417	benzonatate 200 MG Oral Capsule	PSN	f754cce8-1871-4bd6-9082-86607da9c8ae	1
283417	benzonatate 200 MG Oral Capsule	SCD	f754cce8-1871-4bd6-9082-86607da9c8ae	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-537-10	65162053710	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-10)	2010-06-04	0000-00-00	No	No	Current
65162-537-50	65162053750	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-50)	2010-06-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP 100 mg and 200 mg	Amneal Pharmaceuticals LLC	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	17
Benzonatate Capsules, USP 100 mg and 200 mg	AvKARE	2020-06-15	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg and 200 mg	REMEDYREPACK INC.	2019-07-30	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg and 200 mg	QPharma Inc \| Amneal Pharmaceuticals, LLC \| Denton Pharma, Inc.	2018-03-14	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg and 200 mg	A-S Medication Solutions	2017-10-22	HUMAN PRESCRIPTION DRUG LABEL	14
Benzonatate	Direct RX	2015-11-06	HUMAN PRESCRIPTION DRUG LABEL	2
BENZONATATE	Northwind Pharmaceuticals	2015-05-06	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 100 mg and 200 mg	MedVantx, Inc. \| Amneal Pharmaceuticals of NY LLC \| Blenheim Pharmacal, Inc.	2013-01-03	HUMAN PRESCRIPTION DRUG LABEL	1